The
VMP document shall contain information on the following sections and cover all
aspects of qualifications and validations.

Introduction

Objective

Scope

Validation
policy

Validation
committee

Key
personnel and manpower requirement

Facility
and equipment qualification

Description
of facility including plans

Facility,
utilities qualifications

Description
and listing of equipments

Key
acceptance criteria

Design
qualification (DQ)

Installation qualification (IQ)

Operational qualification (OQ)

Performance
qualification (PQ)

Re-validation
criteria

Description
and listing of protocols

Preventive
maintenance programme

Process
validation

Cleaning
validation

Laboratory
instrument qualification

Analytical
method validation

Computer
validation

Change
control and approvals

Validation
documentation

Validation
plan and schedule

Personnel
training programme

Reasonable
unexpected events (worst case)

Review
of VMP

List
of relevant SOPs

Glossary
of terms

The
VMP shall describe the process of preparation, review and approval of
protocols. The major contents of protocol and report shall be defined to
achieve uniformity in documentation of various protocols.

VMP
shall describe the process of execution, review and approval of the validation.

Key
people / team responsibilities for validations shall be described.

The
VMP shall be printed using format attached. Printing shall be done using the
following guidance :

The
compiled VMP will have serial pagination.

Design,
drawing of the facility shall be included to as annexure to elucidate
description of the facility.

VMP
will be prepared by a team, reviewed by senior team and approved by GM QA &
QC.

The
VMP is a controlled document and will be reviewed once a year. Changes to VMP
can be made through document change control.